Inflatable multi-chambered devices and methods of treatment using the same

ABSTRACT

Inflatable multi-chambered devices are provided for repairing or replacing spinal discs and distracting neighboring vertebral elements. Also included are cushioning devices that may be used in a joint replacement device cushioning system. Further included are kits and systems that include such devices, methods for making such devices, and methods of treating patients in need of such devices. Examples further include cosmetic augmentation and restoration devices.

CROSS REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. application Ser. No.11/761,069 filed on Jun. 11, 2007 (allowed), which claims the benefit ofU.S. Provisional Application No. 60/804,505 filed on Jun. 12, 2006; bothof which applications are hereby incorporated by reference in theirentireties.

FIELD

Example embodiments are generally directed to inflatable multi-chamberedballoon devices, which may be useful for example, for the repair orreplacement of spinal discs, as an inflation device to distractvertebral elements, as a cushioning device for joint replacement, or forcosmetic augmentation or restoration. Example embodiments are alsodirected to kits and systems that include such devices. Exampleembodiments are further directed to methods of treating a patient byinserting such devices into the patient.

BACKGROUND

The intervertebral disc (IVD) permits articulation between adjacentelements of the spine. The disc includes an outer annulus fibrosis andan inner nucleus pulposus. In a healthy disc, the nucleus is a gel thattransmits load and absorbs shock. Loads are constrained axially by theannulus fibrosis. Through degenerative processes and/or trauma, theannulus may fail and release the nucleus, which is then free to flow.

The posterior annulus is typically thinner than the anterior annulus,thus, making failures of the posterior annulus more common. When thesefailures occur, a variety of problems may arise. For example, thecontents of the disc may impinge onto nerve roots and/or the spinalcord, resulting in pain and/or neurological deficits. IVD failures inthe lumbar region of the spine are most common, but failures can occurat any level.

When disc failure occurs and pain is present, discectomy may beindicated to remove the impinging material. A 5-10% recurrence ofpainful extrusion may occur. Loss of the nucleus leads to kinematicchanges to the segment and can accelerate weakening of the annulus anddevelopment of osteophytes at the vertebral endplates. This developmentof ectopic bone may lead to stenosis of the vertebral canal anddetrimental changes to other articulating elements.

Injected liquids and implants have been proposed for insertion into aspinal disc space for different purposes. For example, some proposedsystems include inflated balloons to distract disc space to restore lostheight as preparation for an injected biomaterial or as an implant.Other systems include injecting liquids that harden or thicken in situor hydrogel systems that expand upon exposure to water. The use of suchdevices, however, shares a common weakness, in that a failure of thedevice would tend to lead to rapid expulsion of the filler material, forexample, through a pre-existing defect in the annulus. Such expulsionmay create impingement in the same area that created a need for surgicalintervention in the first place. For example, failure of such a devicemay lead to loss of material from the disc space which may then impingeon neural elements. The loss of any material from such devices may leadto loss of disc height and detrimental changes to segment kinematics.Further, the arrangement of many of these devices would tend to lead toexpulsion of the device itself, if deflated. Additionally, for devicesconstructed from a single chamber, the uneven compression of the disc inflexion and extension can result in improper loading of the disc space.

SUMMARY

Example devices are generally directed to multi-chambered devices, whichmay be useful as intervertebral disc nucleus pulposus augmentation orreplacement devices, as inflation devices to distract neighboringvertebral elements, as cushioning devices for joint replacement, or forcosmetic augmentation, reconstruction or restoration. Examples mayfurther include devices that may be useful in mechanical systems wheredamping is required, or to position or maintain the position, or isolatemachinery or structures. Example devices may include inflatable balloondevices, which include at least two chambers and a filling manifold.Example devices are adapted such that at least one of the chambers, andpreferably multiple chambers, may be filled with a filler material, forexample after insertion of the device into a patient.

Example embodiments are also directed to kits and systems that includeinflatable devices. Such kits and systems may further include variousother items, including, but not limited to filler material, tools ordevices for inserting the inflatable devices into a patient, and/ortools or devices for inserting the filler material into at least onechamber of the inflatable devices, such as a high pressure gun.

Example embodiments are further directed to methods of treating apatient in need of treatment, by inserting into the patient a deflateddevice, and then inserting at least one filler material into at leastone chamber of the inflatable balloon device. Such methods may alsoinclude prior removal of all or part of a disc or other material at oraround the location in the patient where the device is to be inserted.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are top view and cross-sectional views respectively, ofan inflatable device in accordance with example embodiments;

FIGS. 2A and 2B depict cross sectional views of an inflatable device inaccordance with example embodiments;

FIGS. 3A and 3B depict a top view of an inflatable device in accordancewith example embodiments;

FIG. 4 depicts a cross sectional view of an inflatable device inaccordance with example embodiments;

FIG. 5 depicts a cross sectional view of an inflatable device inaccordance with example embodiments;

FIG. 6 depicts a cross sectional view of example embodiments of deviceshaving an encasement around the device;

FIGS. 7-12 depict cross sectional views of example embodiments ofdevices, in which chambers have oval cross sections and are oriented indifferent directions;

FIG. 13 depicts a cross sectional view of example embodiments ofdevices, in which chambers are essentially rectangular upon inflation;

FIG. 14 depicts a cross sectional view an inflatable device inaccordance with example embodiments, in which chambers have variousshapes upon inflation;

FIG. 15 depicts a cross sectional view of an inflatable device inaccordance with example embodiments, in which the chambers have variousshapes upon inflation;

FIGS. 16A and 16B depict a top view and cross-sectional view,respectively, of example embodiments of devices, in which the chambersare designed such that each chamber may contain approximately the samevolume of filler material;

FIGS. 17A and 17B depict front and top views, respectively, of aninflatable device in accordance with example embodiments, having astacked chamber design;

FIGS. 18A and 18B depict front and side views, respectively, of aninflatable device in accordance with example embodiments, having astacked chamber design;

FIG. 19 depicts a cross-sectional view of an inflatable device inaccordance with example embodiments having tubes for filling eachchamber;

FIG. 20 depicts of a cross-sectional view of an inflatable device inaccordance with example embodiments;

FIG. 21 depicts of a cross-sectional view of an inflatable device inaccordance with example embodiments;

FIG. 22 depicts of a cross-sectional view of an inflatable device inaccordance with example embodiments;

FIG. 23 depicts of a cross-sectional view of an inflatable device inaccordance with example embodiments; and

FIGS. 24A and 24B depict cross-sectional views of an inflatable devicein accordance with example embodiments, before and after an outerchamber is expanded.

DETAILED DESCRIPTION

The aspects, advantages and/or other features of example embodimentswill become apparent in view of the following detailed description,which discloses various non-limiting embodiments. In describing exampleembodiments, specific terminology is employed for the sake of clarity.However, the embodiments are not intended to be limited to this specificterminology. It is to be understood that each specific element includesall technical equivalents that operate in a similar manner to accomplisha similar purpose.

Example devices and methods may be used for many different purposes. Forexample, devices may be used to augment or to completely replace lost ordegenerated nucleus pulposus of an intervertebral disc. Example devicesmay also be used as an inflation device to distract neighboringvertebral elements and restore proper anatomical height. Example devicesmay also be used as a total joint replacement device cushioning system,for example to reduce shock loading of articulating surfaces. Thepresent devices may further be used for cosmetic augmentation orrestoration, for example, in situations where providing multiple,isolated chambers to mitigate the loss of integrity of a single chambermay be advantageous. Examples may also have possible uses in mechanicalsystems where damping is required, or to position or maintain theposition, or isolate machinery or structures (e.g., mechanical frameisolation, engine mounts, or earthquake protection for buildings).

Devices and methods according to example embodiments generally include achambered balloon, or multiple balloons, which may distribute loadplaced on the device across each individual chamber. In exampleembodiments, load may be distributed substantially evenly. Variousadvantages of examples of the present devices and methods may varydepending on the desired use of the device. Non-limiting examples ofadvantages may include the following: Where the present devices areinflatable nucleus balloon devices being used as a replacement oraugmentation of the nucleus pulposus, for example, if the device fails,the loss of integrity of a single chamber (or even possibly more thanone chamber depending on the total number of chambers) would expel atmost, only the amount of filler material that was initially used in thefailed chamber(s). Because each chamber may be attached to at least one(in the case of an outermost chamber) and usually two or moreneighboring chambers, failure of a chamber may be mitigated due to loadsharing of neighboring chambers. That is, because the entire loadbearing on the device will not be placed onto the failed chamber alone,but rather will continue to be held by neighboring chambers, less thanall of the filler material in the failed chamber may be expelled.Additionally, in many of the present devices, the center of load may beessentially maintained, even if a chamber fails. Thus, if a singlechamber fails, the overall height of the device may decrease somewhat,but there would be little or no adverse lean induced by the failure ofthe chamber. Where a single chamber failure occurs, the retention ofother chambers limits the likelihood that the device itself may beejected.

The present devices and methods may also be advantageous in embodimentswhere the device is being used to distract neighboring vertebralelements. In these example embodiments, because of the presentmulti-chamber load sharing designs, inflation of the device would tendto stress neighboring endplates more evenly and decrease local loadingthat may be possible with single balloon devices. Further, inflation ofthe present devices would allow a surgeon implanting the device into apatient to check the integrity of the annulus and other structures priorto committing to use of such a device as a permanent implant. For suchuse, the device could be used as an aid for alignment or sizing prior touse of other devices or approaches for spinal fusion. Similar and/oradditional advantages may be realized when devices are being used forother purposes.

As used herein, “a” or “an” may mean one or more. As used herein,“another” may mean at least a second or more.

Unless otherwise specified, as used herein, the terms “device,”“inflatable device,” “inflatable balloon device,” “balloon device,” andthe like, are used somewhat interchangeably herein to refer toinflatable multi-chambered devices provided herein. The term balloonincludes any constructs such as bladders, tubes, or other containedchambers. When specified herein, the term “device” may be used to referto other devices, such as devices useful in inserting or using theinflatable balloon devices.

The term “inflatable” as used herein is intended to mean that a deviceis capable of having a filler material inserted into the device, such asinto one or more chambers or balloons, which may act to enlarge thevolume of the device or one or more chambers or balloons thereof, from adeflated to inflated state. As discussed further below, these terms areintended to be relative with respect to each other and do not requireabsolute deflation or inflation. The terms “inflatable” and “balloon”and derivations thereof, are not intended to require that the devicematerial be elastomeric or capable of stretching, although suchpossibilities are contemplated.

The terms “filled” or “inflated” are intended to mean that the device orchamber has filler material therein or added to it in a desired amount.These terms are not intended to mean that the device or chamber isnecessarily entirely or 100% filled with a filler material (however,such embodiments are within the scope of the term “filled”). Similarly,a “deflated” device or chamber thereof does not necessarily mean thatthe device or chamber is entirely empty. There may be some air, or otherfiller material in a “deflated” chamber. A “deflated” device or chamberis intended to mean that the device or chamber does not include thefiller material in an amount that would be desired after the device isfilled.

The terms “fillers,” “filler material,” and “filling material” are usedinterchangeably herein to mean at least one material that may beinserted into at least one chamber of the present balloon devices.Non-limiting examples of suitable fillers may include for example, oneor more gases (such as air), liquids (such as water, saline and thelike), semi-liquids (such as hydrogels or in an in-situ setting polymerfor example, an elastomeric material), and semi-solids. Example liquidsmay be curing (having the same or different viscosities before and aftercuring) or non-curing.

Example inflatable balloon devices generally include at least twochambers, and according to example embodiments at least three, four,five or six chambers or more. Devices further include at least onefilling manifold, such as a valve or tube or other means through whichfilling material may be inserted into at least one of the chambers. Byway of non-limiting example, generally encompassed are nucleus balloondevices, distraction devices, cushioning devices, plastic surgerydevices, and damping, positioning and/or isolation devices that includeat least two chambers; and at least one filling manifold.

Chambers may include independent chambers, interrelated chambers, orboth. Independent chambers are chambers in which filler material doesnot pass between the chambers after they have been filled. For example,after filling, an opening in each chamber may be closed, such that evenif material may have passed between the chambers prior to such closure,it does not pass between the chambers upon closing of the opening. Itmay be preferable to have at least two independent chambers, such thatif leakage or breakage of a chamber occurs, at least one other chamberremains in tact without losing the filling material therein.

Filling manifolds or other means for filling at least one of thechambers with a filler material may include any apparatus or device thatallows filler material to be inserted into at least one, and preferablyinserted into at least two, of the at least two chambers. This mayinclude for example, at least one way of providing access for a fillermaterial to enter the at least one chamber.

The filling manifold may be further adapted such that it is capable ofstopping filler material from entering or exiting the at least onechamber into which filler is inserted. Thus, the filling manifold ormeans for filling may have a device or method of closing off access tothe chamber(s), for example, to prevent leakage of the filler materialout of the chamber.

The filling manifold may be capable of shutting, sealing, or closingopenings to the at least one chamber individually or substantiallysimultaneously. For example, the filling manifold may allow access tofilling or emptying a single chamber, or more than one chamber, or allof the chambers simultaneously. Similarly, the filling manifold mayallow the sealing of all chambers as independent units. As discussedfurther below, where more than one filling manifold is used, differentcombinations of chambers may be filled or sealed independently ofothers.

Optionally, the filling manifold, such as a ball valve, may have alocking mechanism to place or hold the valve in an open position or inthe shut position when desired. According to example embodimentspositive engagement (e.g., pushing in), may be required to fill chambersvia a filling manifold, such as a ball valve.

FIGS. 1A and 1B depict a top view and a cross sectional view,respectively, of non-limiting inflatable balloon devices constructed inaccordance with example embodiments. FIG. 1A depicts an example devicehaving a filling manifold and multiple chambers to allow for loaddistribution and limit the impact of possible failure of any particularchamber. As depicted in FIGS. 1A and 1B, example embodiments may includefive independent chambers 2, 4, 6, 8, and 10, and a ball valve 12. Theball valve 12 allows for filling of each individual chamber.

FIG. 2A depicts a cross section of an example of an inflatable balloondevice in accordance with example embodiments, having five independentchambers 2, 4, 6, 8, and 10. FIG. 2A depicts a device in which allchambers of the device are inflated. FIG. 2B depicts the same device asFIG. 2A, but with a single chamber 6 having failed (see FIG. 2B). Thefailed chamber 6 is depicted in FIG. 2B as being deflated, having asmaller cross-sectional area, as such failure may result in theexpulsion of filling material. As shown in FIG. 2B, the remainingchambers 2, 4, 8, and 10 remain intact, and may support whatever load isbeing placed on the device, even in the absence of the failed chamber'sability to support load. Example embodiments having more than onechamber are advantageous in that the rate and/or amount of outflowthrough a rupture may be reduced by virtue of having adjacent chambersthat remain intact. Thus, it is possible that even upon failure of achamber, some of the filler material initially inserted into the chambermay remain in the chamber, thus, reducing the volume of material ejectedthrough a rupture and entering unintended portions of a patient's bodycavity.

According to example embodiments, a filling manifold may have a singlefilling point. The use of a single filling point in a filling manifoldor means for filling at least one of the chambers, may allow arelatively simple inflation of the device. If inflation is achievedthrough a single point leading to a manifold distributing fluid toindividual chambers, a means to seal the chambers from neighboring unitsmay be used.

By way of non-limiting example, a valve, such as a ball valve may be asuitable filling manifold or means for filling at least one chamber witha filler material. A rotating valve may have for example, a hole alignedwith openings in each chamber such that when the valve is rotated to oneposition, the chambers may be filled or emptied, and when it is rotatedto another position, the chambers are sealed. The valve may be capableof being shut to seal off the chambers after the at least one chamber isfilled to a desired amount (which may be determined for example, bypressure or volume). The ball valve may be open or shut for example, byrotating the valve, e.g., 90 degrees. By way of further example,rotating the valve, e.g., 180 degrees may open or close a particularcombination of chambers, such as a second and fourth chamber, androtating the valve, e.g., 270 degrees may open or close a differentcombination of chambers.

By way of non-limiting example, FIGS. 3A and 3B depict exampleembodiments in which a rotating valve is used as the filling manifold.As depicted in FIG. 3A, a valve 14 is rotated to a position such thatholes 16, 18, 20, 22, and 24 in the valve are aligned with correspondingopenings in the chambers, such that filling material may be insertedthrough the valve into (or withdrawn from) each of the chambers of thedevice. FIG. 3B depicts the same device as FIG. 3A, however in FIG. 3B,the valve 14 is rotated into a position such that the holes 16, 18, 20,22, and 24 in the valve are not aligned with openings in the chambersand filling material may not be inserted into at least one chamberthrough the valve, escape through the valve, or travel from one chamberto another through the valve.

The use of multiple filling points, for example by use of multiplefilling manifolds, is also contemplated. Multiple filling points maysimplify the device and may also serve to reduce the risk of wholedevice failure in the event of a single-point filling manifold failure.According to example embodiments in which the device has for example,four chambers, there may be two filling manifolds, each allowing thefilling of two chambers. Each manifold may then be sealable, as in thesingle filling point method.

As depicted in FIG. 4, a single filling manifold 26 may be used to fillany or all of the chambers 2, 4, 6, 8, and 10. FIG. 5 depictsembodiments having multiple filling points, e.g., through multiplefilling manifolds 28 and 30. In these example embodiments two fillingvalves are used to fill any or all of the chambers 2, 4, 6, 8 and 10.Depending on the arrangement of openings in the filling manifolds 28 and30, either filling manifold may be used to fill all of the chambers (forexample, if filling manifold 30 is used as a back-up device with thesame capabilities to fill all of the chambers that filling manifold 28has), or the different filling manifolds may be used to fill differentchambers (for example, filling manifold 28 may be used to fill chambers2, 6 and 10, while filling manifold 30 may be used to fill chambers 4and 8).

As discussed further below (see for example, FIGS. 7-12), the presentembodiments are not limited to the use of one or two filling manifolds.Additional filling manifolds may be present and used, for example, asbackup devices with the ability to fill all chambers, or used to fillvarious single chambers or combinations of chambers.

In embodiments in which the filler material includes e.g., gases,liquids, and semi-liquids, a filling manifold that is not permanentlysealed may advantageously offer the ability to open and drain thedevice, for example in the event that the device needs to be removed.Rotating valves, such as those discussed above, and as depicted forexample in FIGS. 3A and 3B, are non-limiting examples of fillingmanifolds or means for filling that may not produce a permanent seal,and thus, allow the possibility of further filling of the device, and/orthe ability to open and drain the device.

As indicated above, valves are only examples of filling manifolds ormeans for filing. Alternative filling manifolds or means for filling atleast one chamber are also contemplated. For example, such analternative means may include tubes that may be sealed by a variety ofmethods, including, mechanically or through heat. Other embodiments mayalso include sealing the filling manifold(s). By way of non-limitingexample, sealing methods may include heat (e.g., laser, hot melting,ultrasound, and RF), mechanical plug (e.g., friction, screw, plug, crimpwith a metal or other device, and suture), chemical (e.g., adhesive) andby friction (e.g., stir weld). Other sealing methods may include forexample one way check valves that may be self-closing or self-sealing.Example embodiments may permanently seal the chamber(s). According toexample embodiments, such a valve may be used to seal a single chamberor multiple chambers.

Chambers and/or balloons of the devices may be made of any suitablematerial for insertion into the body. Each chamber generally includesspace in which to fill the chamber with at least one filler or fillermaterial. Chambers and/or other components of the devices may be forexample, flexible or semi-rigid. It may be advantageous that a chamberis flexible enough to be able to condense, collapse, or compress down insize when it is in a deflated state, such that it is smaller (than in aninflated state) for insertion into a patient. For example, devices inaccordance with example embodiments may be flexible enough such thatthey can be deflated or collapsed small enough to permit insertion ofthe device into a patient through a small cannula. According tonon-limiting example embodiments, prior to insertion into a patient, amulti-chambered implant device can be folded or rolled in such a manneras to allow delivery of the device using minimally invasive surgicalequipment such as tubes or cannulas.

According to example embodiments, devices may be constructed of aflexible polymer that permits high loading. According to exampleembodiments, chambers may be made of a material that permits connectionof neighboring chambers. Thus, according to example embodiments devicesmay include chambers that are attached to one another by a means ofattachment. Non-limiting examples of the means of attachment may includefor example, welding, use of adhesives, or molding. According to exampleembodiments, outside walls of the chambers are attached to each other,either completely or partially (for example where an adhesive connectsoutside walls of at least two chambers together along strips, edges orpoints). The device may also be constructed from a single chamber thatis subdivided into separate chambers through the use of baffles or otherdividing structures. The subdivided chambers may be independent from oneanother or may be connected.

According to example embodiments, devices may be constructed ofsemi-independent rings (or other shapes) attached at a central body.

According to example embodiments, devices may be encased in a sheath 32,as depicted for example in FIG. 6. The sheath may be a separate sheathmade of the same or different material as a balloon and/or one or morechambers of the device. The sheath may be for example, a flexible sheathmade from any suitable material, such as a sheet material, whethercontinuous, woven, braided, or a combination thereof. Sheet materialsmay include for example, natural and/or synthetic polymers. The sheathmay be a reinforcing material. Thus, according to example embodiments,devices may include at least two independent chambers surrounded byreinforcing material, such as a mesh or braid. According to exampleembodiments, the sheath may not prevent the chambers or the device as awhole from reducing size when it is in a deflated state (for example forinsertion into or removal from a patient).

Chambers may be any suitable shape (round, oval, square, rectangular,trapezoidal, honeycomb, or other shapes) (see for example, FIGS. 7-12)and/or size depending on the desired insertion location and purposewithin a patient. Although cross-sectional shape variations are depictedin FIGS. 7-12, variations in size and/or shape occur in all dimensionsand may relate for example, to the shape or size as seen from a top viewas well. Suitable variations of the cross section may permit forexample, restoration of lordosis or kyphosis in a patient. According toexample embodiments (see e.g., FIGS. 18A-18B), the device may be shapedin such a way as to correct for abnormal curvature and/or restoration ofnormal curvature of the spine.

FIGS. 7-12 depict example embodiments in which a cross-sectional view ofthe chambers are essentially oval in shape. The chambers may bepositioned with the ovals 36 end to end as depicted in FIGS. 7 and 8, orwith ovals 44 side to side, e.g., with the flatter part of the ovalstouching one another as depicted in FIGS. 9-12. The embodiments depictedin FIGS. 8, 10, 11 and 12 may be advantageous for example, inembodiments where more than one filling manifold is desired for fillingor emptying the chambers. FIGS. 7 and 9 depict embodiments having onefilling manifold 34 and 42. FIGS. 8 and 10 depict embodiments having twofilling manifolds each (38 and 40 in FIGS. 8, and 46 and 48 in FIG. 10).FIG. 11 depicts embodiments having three filling manifolds 50, 52 and54, and FIG. 12 depicts embodiments having four filling manifolds 56,58, 60 and 62. It should be recognized that the shape, size and numberof chambers, and the shape, size and number of filling manifolds can allbe varied.

FIG. 13 depicts other example embodiments in which the cross sections ofthe chambers 64 are similar in size and shape to one another and aregenerally rectangular in shape. FIGS. 14 and 15 depict embodiments inwhich the cross-sections (66, 68, 70, 72 and 74 in FIGS. 14, and 76, 78,80, 82 and 84 in FIG. 15) of the chambers vary in shape and form adesired shape, for the intended use of the device, for example forinsertion into a particular location in a patient.

According to example embodiments, chambers are designed such that eachchamber may contain approximately the same volume of filler material.FIG. 16A depicts a top view of an example of such embodiments, and FIG.16B depicts a cross-sectional view. As shown in FIG. 16A, when viewedfrom the top, the outermost chamber 86 has a greater circumference thaninnermost chamber 88. Therefore, as depicted in FIG. 16B, the outermostchamber 86 may be designed to have a generally smaller cross-sectionalarea than the innermost chamber 88 to arrive at a total volume of theoutermost chamber that is approximately equivalent to the total volumeof the innermost chamber. The term “volume” or “total volume” as used inthis context is intended to mean the total space within a chamber inwhich filler material may be inserted.

In example embodiments, the orientation of the chambers may varydepending on the desired insertion location and purpose. For example,according to non-limiting embodiments, chambers may be stacked upon oneanother, and/or oriented in parallel or in series.

FIG. 17A depicts a front view of an example embodiment having chambers(such as balloons) stacked upon one another. According to the depictedexample chambers 90 and 92 are substantially parallel to one another onopposite sides of a central fill valve 94. FIG. 17B depicts a top viewof this example embodiment, showing the central fill valve 94 by way ofphantom lines.

FIG. 18A depicts a front view of another example embodiment havingchambers (such as balloons) stacked upon one another. According to thedepicted example embodiment, chambers 96 and 98 have non-parallel topand bottom chambers on opposite sides of a central fill valve 100. FIG.18B depicts a side view of this example embodiment, showing the centralfill valve 100 by way of phantom lines.

Numerous possible stacked designs in addition to those depicted hereinare contemplated, including designs having various numbers of chambersin varying sizes, shapes (e.g., round, oval, square, rectangular,trapezoidal, honeycomb, etc), and configurations.

FIG. 19 depicts a top view of another example device. As depicted inFIG. 19, example embodiments may include multiple independent chambers102, 104 and 106, which in this particular embodiment are annular ringswithout a break for a valve. According to the depicted exampleembodiments, a tube 108, which has several branches 110, 112, and 114,allows for filling each individual chamber. The tube 108 may be in anynumber of positions, such as above or below the annular rings.Advantages of these embodiments may include a smaller fill profile, andpotentially simpler fabrication, because any need for attachment of avalve to tubes (such as in other possible embodiments), would beeliminated. These example embodiments may also be advantageous inpermitting greater contact of inflated rings in space that may beoccupied by a valve in other embodiments.

FIGS. 20-23 depict cross-sectional views of various example embodimentshaving chambers 116, 118, 120, and 122, respectively, in various sizes,shapes and configurations. The devices themselves may also be of varioussizes and shapes. As with other embodiments herein, the chambers ofthese embodiments may be connected to other chambers in the same device(such as bonded to one another) or independent from one another.According to example embodiments, a single filling port can be connectedto each chamber via a filling tube (not shown in FIGS. 20-23). Accordingto further example embodiments, a one-way valve on each chamber mayseparate the chambers from one another.

According to example embodiments, at least two chambers are surroundedby an outer balloon or film. The outer balloon or film may be designedto be capable of providing a custom fit to a surgical site. By way ofnon-limiting example, FIGS. 24A and 24B depict a multi-chambered balloon124 surrounded by an outer balloon 126. The outer balloon may be highlyelastic. Using a filling port, the outer balloon 126 may be filled, suchthat it may position or hold the multi-chambered balloon in a desiredlocation, such as substantially at the center of a disc. FIG. 24Adepicts the example embodiment before the outer balloon 126 is filledand expanded, and FIG. 24B depicts the example embodiment after fillingand expansion of the outer balloon 126.

In accordance with example embodiments, devices may further include thefiller material itself. Example filler material may advantageouslypossess similar properties to material being replaced. For example, inembodiments where the device is being used for the replacement oraugmentation of nucleus pulposus, the filling material may possesssimilar properties to nucleus pulposus after being inserted intodevices.

In embodiments where the device is to be inserted into a patient, thefiller material may be a resorbable material that would be relativelyquickly absorbed by the site if a rupture of any part of the deviceoccurs, thus, releasing filler material into the body cavity of apatient. According to example embodiments, a fast resorbing fillermaterial may be used, such that any impingement on any surrounding nervetissue (in the case of rupture of a chamber) would likely be temporary.Example fillers may be degradable or non-degradable.

Advantages may be obtained by using a reverse phase gel as the fillermaterial for embodiments where the device is for implantation into apatient. Reverse phase gels are liquid at room temperature and set intoa higher viscosity gel once exposed to a higher temperature, such asbody temperature. These types of gels could be relatively easilyinjected into chambers of the device in a liquid state or at least in astate that has lower viscosity than after insertion (for example, atroom temperature), and thus, minimize filling pressures. Once injected,the filler material would warm to body temperature, and a gel withimproved mechanical properties would form. According to exampleembodiments, a phase change to this or other filler material may takeplace by a change in pressure, pH, light exposure, temperature changeand/or other factors.

In the gel state, the filler material would be less likely to rupturethe balloon chambers and migrate away from the implant device, thanother filler materials (e.g., liquid or gas filler materials). Anon-limiting example of such gel fillers may include for example, ahydrogel, such as a non-resorbable hydrogel that is liquid at roomtemperature, but gels at body temperature. Example hydrogels may includeone or more components. Example embodiments may include hydrogels forwhich a phase change may be initiated by pressure, pH, light exposureand/or temperature.

The degree to which a particular chamber has been filled may bedetermined for example, by pressure or volume. For example, a pressuregauge in or on the device may be used to determine if one or more of thechamber(s) are filled or deflated to a desired amount. Accordingly,example devices may further include a pressure gauge, or a transducercapable of transmitting pressure as a signal to a remote readout, orother means of detecting the pressure and/or volume in a chamber.According to example embodiments, the filling end point is based onpressure rather than on volume, which may be advantageous in the eventthat the disc space is filled before the device is filled (e.g., when adevice is selected that has a capacity larger than the space it isfilling, or when nucleus material remains in the disc space). Accordingto example embodiments a sensor may be embedded in the device orexternally in the filling system, to allow measurement e.g., of pressurewhen combined with a suitable readout for the sensor.

The filling manifold may be adapted such that the chamber being filledmay be manually or automatically closed off after it is filled to adesired amount or to a desired pressure.

Example devices may further include the use of a radiolucent orradiopaque balloon film or filler material. By including radiolucent orradiopaque dyes in the implant devices and/or in the filler material,the device's position for example, during placement into a patient, maybe visualized on a radiographic image. Such visualization may help indetermining if the implant is properly inflated and/or properlypositioned for example within a patient. For example, visualization mayhelp determine if the implant is properly positioned within thepatient's nucleus cavity.

According to example embodiments, devices may be constructed such thatthere is little or no protrusion from the device, for example, in theway of valves and inlets. Such a design may be advantageous, forexample, in limiting the possibility that the device or elements thereofmay impinge on neural elements.

According to non-limiting example embodiments, a nucleus replacementdevice for an intervertebral disc is provided, which includes amulti-chambered inflatable balloon made of a flexible material; at leastone filling manifold adapted to allow a filler material to be insertedinto at least one of the chambers via the filling manifold; a pressuredetector adapted to detect pressure within at least one of the chambers;and a sealing means to prevent the filler material from entering orexiting at least one of the chambers.

Also included are methods of making inflatable devices provided herein.

Further included are kits that include at least one inflatable balloondevice, which have at least two chambers and at least one fillingmanifold or other means for filling at least one of the chambers. Kitsmay further include one or more devices, tools, materials and the likethat may be included in or with the inflatable balloon device (e.g., thematerial to be inserted therein, pressure gauge, transducer, radiolucentand/or radiopaque dye, etc. . . . ). According to example embodiments,kits may include one or more devices, tools, materials and the likewhich may assist in inserting the device into a patient and/orextracting the device from a patient. It may be advantageous to use asingle instrument that may be used for placement and filling of thedevice.

According to example embodiments, kits may include devices, tools,materials, etc. which may be useful in inserting filler material intothe device (e.g., a high pressure gun), or for removing filler materialfrom the device. Kits may include at least one component for determiningwhen a desired filling point has been achieved. Kits may further includedevices, tools, materials, etc., which may be used for opening themanifold(s) or chamber(s), (such that filler material may be insertedinto or removed from the device), or for closing the manifold(s) orchamber(s), (such that material does not escape (e.g., a tool forrotating the filling manifold)).

Kits may also include tools or devices that may be useful in preparing apatient for insertion of the device into the patient (such as tools forremoving a spinal disc or portions thereof prior to insertion of thedevice).

Kits may include at least one component for visualizing the devicewithin a patient.

Example embodiments are further directed to methods of treating apatient, which include inserting into a patient in need of treatment, aninflatable device, such as those described herein. Methods may includefor example, inserting the device into a patient (for example through atube or cannula), where the device is in a deflated state and theninflating the device after insertion, for example, by inserting a fillerinto at least one chamber of the device. Example methods where thedevice is inflated or expanded within a particular location of apatient, such as within the disc space, may be advantageous for examplewith respect to minimizing any likelihood of device ejection.

A patient in “need of” treatment is intended to encompass situations inwhich treatment is medically necessary, as well as where treatment ismedically advisable, or where treatment is desired but optional. Forexample, the patient may be in need of intervertebral disc nucleuspulposus augmentation or replacement, may have a need for a device thatmay require distraction of neighboring vertebral elements, may be inneed of joint replacement, and/or may be in need of cosmeticaugmentation or restoration.

According to example embodiments, when devices are replacing a disc orportion thereof, a disc or portion thereof may be removed from thepatient prior to insertion of the device. For example, the nucleuspulposus may be substantially or completely removed from a patient, adeflated balloon device inserted into the new substantially emptynucleus cavity, and the balloon device inflated to a desired amount. Byway of example, the balloon may be inflated until the nucleus space isfilled, or to some other desired amount.

Example methods may further include closing openings in the device, suchas in the chamber(s) or the filling manifold or means, such that fillermaterial does not escape or leak out of the one or more chambers, ortravel between chambers after the chambers are filled. By way ofnon-limiting example, in embodiments where the balloon device includes aball valve, the valve may be shut by rotating the valve after inflationof the chambers to the desired pressure and/or volume.

Example methods may also include ensuring that primarily or only desiredmaterial is introduced into the device.

According to example embodiments, before performing or as part ofmethods, it may be advantageous to inject a substance, such as a dyeinto the patient, for example, into the nucleus to determine forexample, the degree and/or location of damage, such as damage to thespinal disc. Diagnostic procedures currently being used to determine thedegree of damage of a spinal disc may include for example, placing aneedle in the nucleus and injecting a dye for fluoroscopicvisualization. As would be apparent to those skilled in the art, otherdiagnostic procedures may be utilized in the example methods, which maybe suitable to assist these methods. By way of non-limiting example,diagnostic procedures encompassed by the present methods may includethose that determine the degree or location of damage, or those that mayassist in positioning the device or determining the amount of filling.The information obtained from such a procedure may assist in theselection of the particular device for insertion (e.g., size or shape ofthe device; number, shape and/or size of chambers; etc.) and/or the typeor amount of filler used (e.g., whether to use air or hydrogel, to whatheight, volume or pressure to fill the chambers, etc).

Example methods may include removing a device, as described herein, froma patient, which includes removing filler material from the device inthe patient, deflating the device (which may automatically occur uponremoval of the filler material), and extracting the device from thepatient.

Example embodiments are further directed to systems that may include aninflatable balloon device as described herein, and at least oneadditional component, such as those that may be suitable for inclusionin kits discussed herein, such as the filler material itself. Systemsmay also include pressure gauges, transducers, or other means fordetermining the amount of filling inserted into the device and the like.Systems may include means for visualization of devices, such ascomputers, computer monitors and any other components that may be usefulfor such visualization.

According to example embodiments, the present devices may be cushioningdevices, which may be used for example, as part of a total jointreplacement device cushioning system. Cushioning may advantageouslyreduce impulses transmitted through total joint bearing materials, andmay help restore functional shock absorption that may be lost withdamage or removal of articulating cartilage. Such damping may be ofparticular use where metal-on-metal, metal-on-ceramic, orceramic-on-polymer articulations are currently used. Damping may beuseful for traditional metal-on-polymer designs as well, to reduce theeffect of shock loading seen on relatively small contact areas, as isthe case for example, with total knee, ankle and shoulder replacements.Cushioning devices may be useful for example, with respect to any areawhere joints are replaced, including, but not limited to, spine, wrist,fingers, and toes.

Devices in accordance with these example embodiments may be tailored bythose skilled in the art having reviewed this disclosure specificallyfor use as a cushioning device, for example, as part of a total jointreplacement device cushioning system. It would be apparent to thoseskilled in the art that the filler material in such a cushioning devicemay be different than a filler material used in devices e.g., fordistracting neighboring vertebral elements. Similarly, those skilled inthe art would be able to determine the appropriate shapes and sizes ofsuitable devices for use as a total joint replacement cushioning system,and that such shapes and sizes may be different from those of devicesused for different purposes.

Accordingly, examples include cushioning devices having at least twochambers; and at least one filling manifold adapted to allow a fillermaterial to be inserted into at least one of the at least two chambersvia the filling manifold. Further embodiments include systems and kitsthat include such devices. Systems and kits may further include one ormore devices, tools, materials and the like that may be useful withrespect to joint replacement and methods of performing jointreplacement.

Further included are methods of replacing a joint, which includeinserting into a patient in need of joint replacement, at least onecushioning device that includes at least two chambers; and at least onefilling manifold adapted to allow a filler material to be inserted intoat least one of the at least two chambers via the filling manifold. Suchmethods may further include one or more steps that would be useful injoint replacement or other methods where a cushioning device would beused. For example, methods may include removal of cartilage or othercomponents prior to insertion of the device into a patient.

These example embodiments may include other aspects as described herein,which would be apparent to those skilled in the art reading thisdisclosure.

It is also contemplated that the present devices may be devices adaptedfor plastic surgery augmentation, reconstruction, restoration, and/ortissue expansion. For example devices may be cosmetic devices used inareas of the body where filled implants are typically used, e.g., tissueexpanders, cheek implants, gluteal implants, breast implants, etc. . . .Accordingly, also included are plastic surgery and reconstructionimplant devices that include at least two chambers; and at least onefilling manifold adapted to allow a filler material to be inserted intoat least one of the at least two chambers via the filling manifold.These example embodiments may include other aspects as described herein,which would be apparent to those skilled in the art reading thisdisclosure. For example, in these example embodiments, it may beparticularly advantageous to not have the filling manifold (e.g., valve)extruding from the device, or be visible or palpable in any way.

Also included are kits and systems including such implants and methodsof treatment that include inserting such implants into a patient in needthereof.

It is also contemplated that the present devices may be used as dampingdevices in mechanical systems where damping is required or to positionor maintain the position, or isolate machinery or structures (e.g.,mechanical frame isolation, engine mounts, earthquake protection forbuildings). The present fillable devices may be useful in suchmechanical systems, for example, for purposes of simplifiedinstallation, replacement, and/or maintenance.

Accordingly, example embodiments are directed to damping devices thatinclude at least two chambers; and at least one filling manifold adaptedto allow a filler material to be inserted into at least one of the atleast two chambers via the filling manifold. Such devices may optionallyincorporate sensors (for example, to measure position, pressure,temperature, etc.). An advantage of using such devices in theseapplications may include the ability to tailor chamber cross section(s)and orientations (e.g., stacked, used in parallel or series) forintended use. Just as with other embodiments, the present devices areadvantageous in that the failure of a chamber would not lead to totalsystem failure. Further included are kits and systems including suchdevices, and methods for their use.

These example embodiments may include other aspects as described herein,which would be apparent to those skilled in the art reading thisdisclosure.

The following example illustrates specific embodiments. The example setforth herein is meant to be illustrative and should not in any way serveto limit the scope of the claims. As would be apparent to skilledartisans, various changes and modifications are possible and arecontemplated, and may be made by persons skilled in the art.

EXAMPLE

This prospective example sets forth a method for replacing the nucleuspulposus in a patient, using example devices. A patient having a spinaldisc defect is prepared for surgery and the nucleus pulposus of thepatient is removed. A device is selected, based on various factors,which may include for example, the size and shape of the cavity to befilled and the relative load to be placed on the device. According tothis example, a device having five independent inflatable chambers and arotating valve as a filling manifold may be provided. The device is madeof a flexible material and is provided in a substantially deflatedstate, such that it is maneuverable and takes up a relatively smallarea. Prior to insertion, the device is rolled or folded in such amanner as to allow its delivery using minimally invasive surgicalequipment such as tubes or cannulas. The device is inserted into thecavity of the patient and positioned within the patient usingradiography or other visualization techniques.

All of the chambers are then filled through a single rotating valvehaving holes corresponding to openings in each of the chambers. Therotating valve is positioned such that holes in the valve align withopenings in the chambers. Then, a fast resorbing reverse phase hydrogelis inserted through the valve (in liquid form), such that the liquidform of the gel flows into each of the chambers.

A pressure gauge on the device or a transducer capable of transmitting asignal to a remote device, indicates to the physician when the chambershave been filled to a desired amount, such that the surgeon stops theflow of the filler material into the chambers after the desired pressureis reached. It is contemplated that the filling (or stoppage thereof)may be somewhat automated, such that filling stops automatically upon apressure or volume range reaching a pre-set level. Filling may also bestopped by rotating the ball valve 90 degrees to a closed position suchthat the holes of the ball valve are no longer aligned with thechambers. Regardless of how filling is actually stopped, the chambersare sealed after filling to prevent leakage of the filler material outof the chambers.

The hydrogel filler material gels upon reaching body temperature. Anyload placed on the device may be distributed or shared among thedifferent chambers.

Although the invention has been described in example specificembodiments, many additional modifications and variations would beapparent to those skilled in the art. For example, many modificationsmay be made by those skilled in the art to the example devices,including for example to the number, size, shape and placement ofvarious chambers, as well as the type, number and configuration offilling manifolds. Other modifications may be made for example to themethods, including the addition of or changing the order of varioussteps. It is therefore to be understood that the invention may bepracticed other than as specifically described. Thus, the presentembodiments should be considered in all respects as illustrative and notrestrictive.

1. An inflatable balloon device comprising at least three independent,adjacent hollow tube chambers, wherein each tube is curved to form aring and the rings are arranged concentrically around an axis,substantially in a plane perpendicular to the concentric axis; and atleast one filling manifold adapted to allow a filler material to beinserted at least partially concurrently into at least two of said atleast three hollow tube chambers; wherein said inflatable balloon deviceis adapted to distribute load placed on the inflatable balloon deviceafter filling, across multiple of the at least three hollow tubechambers.
 2. The inflatable balloon device of claim 1, furthercomprising a filler material within at least one of said at least threetube chambers, wherein said filler material is at least one materialselected from the group consisting of gas, liquids, semi-liquids, andsemi-solids.
 3. The inflatable balloon device of claim 2, wherein saidfiller material is at least one material selected from the groupconsisting of hydrogel, air, water, and saline.
 4. The inflatableballoon device of claim 1, further comprising a pressure detector withinat least one of said chambers.
 5. The inflatable balloon device of claim1, further comprising at least one dye selected from the groupconsisting of a radiolucent dye and a radiopaque dye.
 6. The inflatableballoon device of claim 1, wherein said device further comprises asheath encasing said chambers and said filling manifold.
 7. Theinflatable balloon device of claim 1, further comprising a sealing meansto prevent filler material from entering or exiting at least one of thechambers.
 8. The inflatable balloon device of claim 7, wherein thesealing means is selected from the group consisting of heat, amechanical plug, chemical means, a one way check valve, and friction. 9.The inflatable balloon device of claim 1, wherein said at least threechambers are surrounded by a reinforcing material.
 10. The inflatableballoon device of claim 1, wherein said device is adapted for at leastone of the following: replacement or augmentation of nucleus pulposus;distraction of neighboring vertebral elements; cushioning in a jointreplacement system; plastic surgery augmentation, reconstruction,restoration, or tissue expansion; and damping, positioning, or isolationin a mechanical system.
 11. A nucleus replacement device comprising: amulti-chambered inflatable balloon having at least three independentadjacent hollow tube chambers comprising a flexible material, whereineach tube is curved to form a ring and the rings are arrangedconcentrically around an axis, substantially in a plane perpendicular tothe concentric axis; at least one filling manifold adapted to allow afiller material to be inserted at least partially concurrently into atleast two of said hollow chambers via the filling manifold; a pressuredetector positioned within at least one of said chambers, said pressuredetector being adapted to detect pressure within at least one of saidchambers; and a sealing means to prevent the filler material fromentering or exiting at least two of the chambers.
 12. The nucleusreplacement device of claim 11, wherein said at least one fillingmanifold is selected from the group consisting of at least one valve andat least one tube.
 13. The nucleus replacement device of claim 11, saiddevice further comprising a sheath encasing said chambers and saidmanifold.
 14. The nucleus replacement device of claim 11, wherein thesealing means is selected from the group consisting of heat, amechanical plug, chemical means, a one way check valve, and friction.15. The nucleus replacement device of claim 11, wherein said chambersare surrounded by a reinforcing material.
 16. A kit comprising theinflatable balloon device of claim
 1. 17. The kit of claim 16, furthercomprising at least one additional component selected from the groupconsisting of: a device for inserting said inflatable balloon deviceinto a patient in need thereof; filler material; a device for insertingfiller material into the inflatable balloon device; at least onecomponent for visualizing said device within a patient; and at least onecomponent for determining when a desired filling point has beenachieved.
 18. A system comprising the inflatable balloon device of claim1; and a filler material.
 19. The system of claim 18, further comprisinga high pressure gun for inserting the filler material into at least oneof the at least three chambers.
 20. A method of treating a patientcomprising: inserting the inflatable balloon device of claim 1 into apatient in need thereof, wherein the device is an a deflated state uponinsertion into the patient; and inflating the device by inserting afiller material into at least one chamber of the device.
 21. The methodof claim 20, wherein the filler material is inserted with a highpressure gun.
 22. The method of claim 20, further comprising sealing theinflated device, wherein said sealing is selected from the groupconsisting of heat, mechanically plugging, chemically sealing, friction,and closing the at least one rotating ball valve.
 23. The method ofclaim 20, wherein said inflatable balloon device is inserted into apatient through a tube or cannula.
 24. A method of removing a deviceaccording to claim 1 from a patient comprising removing filler materialfrom the device in the patient to deflate the device; and extracting thedeflated device from the patient.
 25. An inflatable nucleus replacementdevice comprising: a multi-chambered inflatable balloon comprising atleast three independent, adjacent, hollow tube chambers comprising aflexible polymer material, wherein each tube is curved to form a ringand the rings are arranged concentrically around an axis, substantiallyin a plane perpendicular to the concentric axis; at least one fillingmanifold adapted to allow a filler material to be inserted at leastpartially concurrently into at least two of said at least threeindependent, adjacent, hollow tube chambers; and a pressure detectorpositioned within at least one of said chambers, said pressure detectorbeing adapted to detect pressure within at least one of said chambers;wherein said inflatable nucleus replacement device is adapted todistribute load placed on the inflatable nucleus replacement deviceafter filling, across multiple of the at least three chambers.